[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Rules and Regulations]
[Pages 11598-11599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6077]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Medicated Feed 
Applications; Halofuginone Hydrobromide; Technical Amendment

AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the correct assay limits for halofuginone 
hydrobromide Type A medicated articles. As amended, the regulation 
reflects the assay limits in the approved new animal drug application 
(NADA). This action is being taken to ensure the accuracy and 
consistency of the regulations and to correct an error that occurred 
because the regulation did not reflect the assay limits approved in the 
NADA.

EFFECTIVE DATE: March 10, 1998.

FOR FURTHER INFORMATION CONTACT: Mary G. Leadbetter, Center for 
Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1662.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 21, 1985 
(50 FR 33718), FDA added Sec. 558.265 (21 CFR 558.265) to reflect 
approval of Hoechst Roussel Vet's NADA 130-951 for the use of 
halofuginone hydrobromide Type A medicated articles. Section 558.265 
provided for the use of the Type A article to make Type C feed. Section 
558.265 also provided the approved assay limits for

[[Page 11599]]

the Type C medicated feeds of 75 to 125 percent of the labeled amount. 
The assay limits for the halofuginone Type A medicated articles of 90 
to 115 percent of labeled amount in the approved NADA were not 
published at that time.
    In the Federal Register of March 3, 1986 (51 FR 7382 at 7393), FDA 
added Sec. 558.4 (21 CFR 558.4) providing for the regulation of 
medicated feed applications. In Sec. 558.4, FDA incorrectly published 
the assay limits for Type A articles of 80 to 120 percent of the 
labeled amount. At this time, FDA is amending the assay limits for Type 
A medicated articles to reflect those levels in the approved 
application. Accordingly, FDA is correcting Sec. 558.4(d) to provide 
for an assay limit for halofuginone hydrobromide Type A medicated 
articles of 90 to 115 percent of the labeled amount instead of 80 to 
120 percent.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec. 558.4   [Amended]

    2. Section 558.4 Medicated feed applications is amended in 
paragraph (d), in the table entitled ``Category II'', in the entry 
``Halofuginone hydrobromide'' in the second column by removing ``80-
120'' and adding in its place ``90-115''.

    Dated: February 26, 1998.
Steven D. Vaughn,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-6077 Filed 3-9-98; 8:45 am]
BILLING CODE 4160-01-F